(582 days)
Not Found
No
The summary describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities. The "Arrhythmia analysis" is a common feature in patient monitors and does not necessarily imply the use of AI/ML.
No
The device is described as a "patient monitor" intended for "monitoring, displaying, alarming and storing of multiple physiological parameters." It provides diagnostic information but does not actively treat or intervene in a therapeutic manner.
No
Explanation: The device is described as a "patient monitor" and its intended use is for "monitoring, displaying, alarming and storing of multiple physiological parameters." While it provides data, it is not described as analyzing that data to diagnose a specific condition.
No
The device description explicitly states that the NC10 and NC12 are "patient monitors" and describes "hardware design principle" and "parameters measurement subsystems (including parameters modules and accessories)". This indicates the device includes hardware components beyond just software.
Based on the provided information, the NC10 and NC12 patient monitors are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The NC10 and NC12 patient monitors directly measure physiological parameters from the patient's body (ECG, SpO2, NIBP, etc.) using sensors and electrodes applied externally or invasively. They do not analyze samples taken from the body.
- Intended Use: The intended use clearly states "monitoring, displaying, alarming and storing of multiple physiological parameters" of a single patient. This is consistent with patient monitoring, not in vitro analysis of specimens.
Therefore, the NC10 and NC12 patient monitors fall under the category of patient monitoring devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, alarming and storing of multiple physiological parameters These parameters include ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
- BIS monitoring is intended for adult and pediatric patients only;
- C.O. monitoring is restricted to adult patients only;
- Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
- When using COMEM SpO2, the monitor is intended to be used on adult patients only.
- NIBP measurement continual mode is not applicable to neonates.
The monitors are to be used in general healthes by clinical physicians or appropriate medical staff under the direction of physicians.
The monitors are not intended for helicopter transport, hospital ambulance, or home use.
The monitors do not measure, display, or trend changes in the ST segment.
The monitors do not intend for use as apnea monitors.
The monitors are not intended for use in MRI or CT environments.
The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointe.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSI, MLD, DRT, DSJ, DXN, DSK, DPS, DXG, DSB, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, NHQ, NHO, NHP, OLW, GXY
Device Description
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing multiple physiological parameters. These parameters include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
BIS monitoring is intended for adult patients only; C.O. monitoring is restricted to adult patients only; Arrhythmia analysis is intended for use with adult patients only and is not intended and shall not be used on pediatric and neonatal population. When using COMEM SpO2, the monitor is intended to be used on adult patients only. NIBP measurement continual mode is not applicable to neonates. Both models are designed with:
Same system framework and components
Same hardware design principle
Same software platform
Same parameters measurement subsystems (including parameters modules and accessories)
The only difference between NC10 and NC12 is the display size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric, and neonatal patients.
BIS monitoring is intended for adult and pediatric patients only.
C.O. monitoring is restricted to adult patients only.
Arrhythmia analysis is intended to use on adult patients only.
When using COMEM SpO2, the monitor is intended to be used on adult patients only.
NIBP measurement continual mode is not applicable to neonates.
Intended User / Care Setting
General healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Biocompatibility Testing
The accessories with patient contact have been evaluated by biocompatibility testing in accordance with ISO 10993-1.
Bench test
The NC10 and NC12 Multi-parameter Patient Monitor have been tested and found to be in compliance with the following safety, performance and electromagnetic compatibility standards:
- ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2 Edition 4.0: 2014-02 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- IEC 60601-1-8 Edition 2.1 2012-11Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety And Essential Performance - Collateral Standard: General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems
- IEC 60601-2-27 Edition 3.0 2011-03 Medical Electrical Equipment - Part 2-27: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographic Monitoring Equipment [Including: Corrigendum 1 (2012)]
- IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- IEC 60601-2-34 Edition 3.0 2011-05 Medical Electrical Equipment - Part 2-34: Particular Requirements For The Basic Safety, Including Essential Performance, Of Invasive Blood Pressure Monitoring Equipment
- ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
- ISO 80601-2-61 Second Edition 2017-12 Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment
- ISO 80601-2-55 Second Edition 2018-02 Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic Safety And Essential Performance Of Respiratory Gas Monitors
- ANSI AAMI EC57:2012 Testing And Reporting Performance Results Of Cardiac Rhythm And ST-Segment Measurement Algorithms
- IEC 80601-2-49:2018 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment.
- IEC 80601-2-26:2019 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs.
- EN 1060-1:1995+A2:2009 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
- EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
- IEC 60601-1-6 Edition 3.1 2013-10 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
- IEC 62366-1 Edition 1.0 2015-02 Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices [Including CORRIGENDUM 1 (2016)]
- ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
Clinical studies
The clinical accuracy of non-invasive blood pressure (NIBP) determination, SpO2 measurement, and respiratory rate were validated for the intended patient population. Clinical data is provided to support the determination of substantial equivalence with predicated devices that are currently marketed for the same intended use.
- The accuracy of the SpO2 accuracy during non-motion conditions as compared to CO-oximetry in a controlled desaturation study was validated using the method outlined in ISO 80601-2-61:2017 and the FDA guidance Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, March 2013.
- The clinical accuracy of non-invasive blood pressure determination was validated according to ISO 81060-2 which contains the requirements for clinical accuracy and the protocols for investigating the NIBP determination clinical accuracy.
- The clinical accuracy of respiratory rate was validated by clinical testing to compare the measurement of the subject device and that of a clinician-scored capnography device, manually scored end-tidal CO2 (EtCO2) capnography.
All clinical accuracy validation studies were conducted in accordance with standard ISO 14155:2020.
Summary
Based on the non-clinical and clinical performance above, we demonstrate that the NC10 and NC12 multi-parameter patient monitors were substantially equivalent and perform as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
December 29, 2022
Shenzhen Comen Medical Instruments CO., LTD. Charlotte Lin Jingfang International Registration Engineer FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-District, Guangming District Shenzhen, Guangdong 51806 China
Re: K211619
Trade/Device Name: Multi-Parameter Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DSJ, DXN, DSK, DPS, DXG, DSB, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, NHQ, NHO, NHP, OLW, GXY Dated: December 2, 2022 Received: December 2, 2022
Dear Charlotte Lin Jingfang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shruti N. Mistry -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211619
Device Name
Multi-parameter Patient Monitor, model: NC10, NC12
Indications for Use (Describe)
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, alarming and storing of multiple physiological parameters These parameters include ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
- · BIS monitoring is intended for adult and pediatric patients only;
- · C.O. monitoring is restricted to adult patients only;
· Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
- · When using COMEM SpO2, the monitor is intended to be used on adult patients only.
- · NIBP measurement continual mode is not applicable to neonates.
The monitors are to be used in general healthes by clinical physicians or appropriate medical staff under the direction of physicians.
The monitors are not intended for helicopter transport, hospital ambulance, or home use.
The monitors do not measure, display, or trend changes in the ST segment.
The monitors do not intend for use as apnea monitors.
The monitors are not intended for use in MRI or CT environments.
The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.
| Type of Use (Select one or both, as applicable) |
|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
[X] Prescription Use (Part 21
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3
Section 5 - 510 (k) Summary
NC10 and NC12 Multi-parameter Patient Monitor
This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.
| Date: | 2nd December, 2022 | ||
|---|---|---|---|
| Submitter | SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD | ||
| Address | Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building | ||
| 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, | |||
| Shenzhen, 518106, Guangdong, China. | |||
| Contact | Chuanqing Zhu | ||
| Telephone | +86-18252006698 | ||
| Facsimile | +86-755-3431232 | ||
| Ee-mail | zhuchuanqing@szcomen.com | ||
| Device | |||
| trade | |||
| name | NC10 and NC12 Multi-parameter Patient Monitor | ||
| Common name | Multi-parameter Patient Monitor | ||
| Classification Regulation, Classification name and Product Codes | |||
| Device Panel | Regulation | ||
| Classification | |||
| number | Product | ||
| code | Description | ||
| Cardiovascular | §870.1025, II | MHX | Arrhythmia detector and alarm (including |
| ST-segment measurement and alarm) | |||
| Cardiovascular | §870.1025, II | DSI | Arrhythmia detector and alarm (including |
| ST-segment measurement and alarm). | |||
| Cardiovascular | §870.1025, II | MLD | Arrhythmia detector and alarm (including |
| ST-segment measurement and alarm). | |||
| Cardiovascular | §870.2300, II | DRT | Monitor, Cardiac (Including |
| Cardiotachometer & Rate Alarm) | |||
| Cardiovascular | §870.1100, II | DSJ | Alarm, Blood-Pressure |
| Cardiovascular | §870.1130, II | DXN | System, Measurement, Blood-Pressure, |
| Non-Invasive | |||
| Cardiovascular | §870.1110, II | DSK | Computer, Blood-Pressure |
| Cardiovascular | §870.2340, II | DPS | Electrocardiograph |
| Cardiovascular | §870.1435, II | DXG | Computer, Diagnostic, Pre-Programmed, |
| Single-Function | |||
| Cardiovascular | §870.2770, II | DSB | Plethysmograph, Impedance |
| General | |||
| Hospital | §880.2910, II | FLL | Thermometer, Electronic, Clinical |
| Anesthesiology | §870.2700, II | DQA | Oximeter |
| Anesthesiology | §868.1400, II | CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous- |
| Phase | |||
| Anesthesiology | §868.1500, II | CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase |
| (Anesthetic Concentration) | |||
| Anesthesiology | §868.1620, II | CBS | Analyzer, Gas, Halothane, Gaseous-Phase |
| (Anesthetic Conc.) | |||
| Anesthesiology | §868.1700, II | CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous |
| Phase (Anesthetic Conc.) | |||
| Anesthesiology | §868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Anesthesiology | §868.1500, II | NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase |
| (Anesthetic Concentration) | |||
| Anesthesiology | §868.1500, II | NHO | Analyzer, Gas, Desflurane, Gaseous-Phase |
| (Anesthetic Concentration) | |||
| Anesthesiology | §868.1500, II | NHP | Analyzer, Gas, Sevoflurane, Gaseous- |
| Phase (Anesthetic Concentration) | |||
| Neurology | §882.1400, II | OLW | Index-Generating Electroencephalograph |
| Software | |||
| Neurology | §882.1320, II | GXY | Electrode, Cutaneous |
| Predicate | |||
| Device: | K191106, C50 and C80 Multi-parameter Patient Monitors, SHENZHEN COMEN | ||
| MEDICAL INSTRUMENTS CO., LTD | |||
| Device | |||
| description: | The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, | ||
| reviewing, alarming and storing multiple physiological parameters. These parameters | |||
| include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), | |||
| Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood | |||
| pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide | |||
| (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient. | |||
| All parameters can be monitored on single adult, pediatric, and neonatal patients except: | |||
| BIS monitoring is intended for adult patients only; C.O. monitoring is restricted to adult patients only; Arrhythmia analysis is intended for use with adult patients only and is not intended | |||
| and shall not be used on pediatric and neonatal population. When using COMEM SpO2, the monitor is intended to be used on adult patients only. NIBP measurement continual mode is not applicable to neonates. Both models are designed with: | |||
| Same system framework and components | |||
| Same hardware design principle | |||
| Same software platform | |||
| Same parameters measurement subsystems (including parameters modules and accessories) | |||
| The only difference between NC10 and NC12 is the display size. | |||
| Indications for | |||
| Use: | The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, | ||
| reviewing, alarming and storing of multiple physiological parameters. These parameters | |||
| include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), |
4
5
| | Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood
pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide
(CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
• BIS monitoring is intended for adult and pediatric patients only;
• C.O. monitoring is restricted to adult patients only;
Arrhythmia analysis is intended to use on adult patients only and is not intended and shall
not be used on pediatric and neonatal population.
• When using COMEM SpO2, the monitor is intended to be used on adult patients only.
• NIBP measurement continual mode is not applicable to neonates. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The monitors are to be used in general healthcare facilities by clinical physicians or
appropriate medical staff under the direction of physicians.
The monitors are not intended for helicopter transport, hospital ambulance, or home use.
The monitors do not measure, display, or trend changes in the ST segment.
The monitors do not intend for use as apnea monitors. |
| | The monitors are not intended for use in MRI or CT environments.
The monitors are not used on patients who have a demonstrated need for cardiac monitoring
known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes. |
| Technological
Comparison to | Both the subject devices and the predicate device provide a means for monitoring one
patient, collecting specific physiological data, processing the data for alarm conditions and |
| Predicate | display of numeric values and waveforms. |
| Devices: | In terms of indications for use, basic operation and performance specifications, the NC10 |
| | and NC12 Multi-parameter Patient Monitor is equivalent to C50 and C80 multi-parameter |
| | Patient Monitors (K191106). All devices can provide monitoring such as ECG(3-lead , 5- |
| | lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate(RR), |
| | Temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive |
| | blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG) and |
| | Bispectral index (BIS)for a single patient. |
| | NC10 and NC12 restricted the arrhythmia analysis, BIS monitoring and COMEN SpO2 on |
| | adults only, which is a subset of C50 and C80 multi-parameter patient monitor. These do |
| | not affect the substantial equivalence of subject device and predicate device. |
| | Table below compares the key technological feature of the subject devices (NC10 and NC12 |
| | patient monitors) to the predicate device (K191106, C50 and C80 multi-parameter patient |
| | monitor). The features in gray are features that are different between the predicate devices |
| | and the subject devices. |
| | Device Comparison Table |
6
| Feature | Predicate device C50
and C80 (K191106) | Subject devices
NC10 and NC12 | Comparison |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Monitor
Size | C80: 344mm×291 mm×
165mm
C50:
291.7mm×250
mm×146.5mm | NC12: 308mm× 257
mm ×142mm
NC10:
265mm
×227mm×141mm | Similar. Both
devices met IEC
60601-1. |
| Integrated
display
screen | color TFT LCD
C80: 12.1 Inch
C50: 10.4 Inch
C80: 800×600 pixels
C50: 800×600 pixels | color TFT LCD
NC12: 12.1 Inch
NC10: 10.4 Inch
NC12: Pixel: 800×600
NC10: Pixel: 800×600 | Same
Same
Same
Same
Same |
| Power
supply | C50 and C80:
Two rechargeable
Lithium-ion battery or
AC power supply | NC10 and NC12:
Two rechargeable
Lithium-ion battery or
AC power supply | Same |
| Battery | 11.1V, 2200mAh or
4400mAh | 11.1V, 2200mAh or
4400mAh | Same |
| ECG | 3-lead, 5-lead and 12-
lead selectable, heart
rate (HR) | 3-lead, 5-lead and 12-
lead selectable, heart
rate (HR) | Same |
| ECG
(Arrhyth
mia
Analysis) | Asystole, ventricular
fibrillation, R ON T,
VT>2, Couplet, PVC,
Bigeminy, Trigeminy,
Brady (Bradycardia),
PNC (Pacer Not
Capture), PNP (Pacer
Not Pace), Missed
Beats, Heart Pause,
Irregular Heart Beat,
VTAC (Ventricular
Tachycardia), Tachy
(Tachycardia), PVCs
Too High, Extreme
Tachycardia, Extreme
Bradycardia,
Ventricular Rhythm, | Asystole, ventricular
fibrillation, R ON T,
VT>2, Couplet, PVC,
Bigeminy, Trigeminy,
Brady (Bradycardia),
PNC (Pacer Not
Capture), PNP (Pacer
Not Pace), Missed
Beats, Heart Pause,
Irregular Heart Beat,
VTAC (Ventricular
Tachycardia), Tachy
(Tachycardia), PVCs
Too High, Extreme
Tachycardia, Extreme
Bradycardia,
Ventricular Rhythm, | Same |
| Respiratio
n | Method: Trans-thoracic
impedance
Range: | Method: Trans-thoracic
impedance
Range: | Same |
| | | | |
| | adult:0-120 rpm; | adult:0-120 rpm; | |
| | pediatrics:0-150rpm; | pediatrics:0-150rpm; | |
| | neonate:0-150rpm | neonate:0-150rpm | |
| | Accuracy: | Accuracy: | |
| | 7 to 150rpm: ±2rpm or
±2%, whichever is
greater. | 7 to 150rpm: ±2rpm or
±2%, whichever is
greater. | |
| | 0 to 6rpm: not specified | 0 to 6rpm: not specified | |
| Pulse
oxygen
saturation
(SpO2) | Method: red and
infrared light method | Method: red and
infrared light method | Same |
| | Masimo SpO2: | Masimo SpO2: | |
| | Range:1100% | Range:1100% | |
| | Accuracy: | Accuracy: | |
| | No motion Conditions: | No motion Conditions: | |
| | 70 to 100%: ±2%(in
adult/pediatric mode) | 70 to 100%: ±2%(in
adult/pediatric mode) | |
| | 70 to 100%: ±3% (in
neonate mode) | 70 to 100%: ±3% (in
neonate mode) | |
| | Motion conditions: | Motion conditions: | |
| | 70%100%: ±3% | 70% 69%: Not100%: ±3% | | 69%: Not
| | 1%
specified. | 1%
specified. | |
| | Nellcor SpO2: | Nellcor SpO2: | Same |
| | Range: 0100% | Range: 0100% | |
| | Accuracy:70 to 100%:
±2% (adult/pediatric) | Accuracy:70 to 100%:
±2% (adult/pediatric) | |
| | 70 to 100%: ±3%
(neonate) | 70 to 100%: ±3%
(neonate) | |
| | 0% to 69%: Not
specified. | 0% to 69%: Not
specified. | |
| | Comen SpO2: | Comen SpO2: | Different. |
| | Range: 0100%; | Range: 0100%; | The subject
devices add |
| | Accuracy: 70 to 100%:
±2% (adult/pediatric
mode) | Accuracy: 70 to 100%:
±3% (adult) | exceptions on
neonate and |
| | 70 to 100%: ±3%
(neonate mode) | 0% to 69%: Not
specified | pediatric use of
Comen SpO2. |
| | 0% to 69%: Not
specified | | The SpO2
accuracy met ISO
80601-2-61 and
was validated by
the clinical study. |
| | | | |
| Pulse
rate(PR) | PR FROM Masimo
SpO2: | PR FROM Masimo
SpO2: | Same |
| | Range: 25240bpm | Range: 25240bpm | |
| | Accuracy: | Accuracy: | |
| | ±3bpm (without
motion) | ±3bpm (without
motion) | |
| | ±5bpm (with motion) | ±5bpm (with motion) | |
| | PR FROM Nellcor
SpO2: | PR FROM Nellcor
SpO2: | |
| | Range:20300bpm | Range:20300bpm | |
| | Accuracy: | Accuracy: | |
| | 20250bpm: ±3bpm | 20250bpm: ±3bpm | |
| | 251300bpm: not300bpm: not
specified. | 251
specified. | |
| | PR FROM COMEN
SpO2: | PR FROM COMEN
SpO2: | |
| | Range: 20bpm
254bpm; | Range: 20bpm150rpm;
254bpm; | |25% (at 760mmHg)
| | Accuracy: ±2bpm; | Accuracy: ±2bpm; | |
| | PR FROM IBP: | PR FROM IBP: | |
| | Range:25-350bpm | Range:25-350bpm | |
| | Accuracy:±1bpm or
±1%, whichever is
greater | Accuracy:±1bpm or
±1%, whichever is
greater | |
| | PR FROM NIBP : | PR FROM NIBP: | |
| | Range: 40 ~ 240 bpm; | Range: 40 ~ 240 bpm; | |
| | Accuracy: ±3bpm or ±3%, whichever is greater | Accuracy: ±3bpm or ±3%, whichever is greater | |
| Non-
invasive
blood
pressure
(NIBP) | Method: Oscillometry
Range:
Adult:
systolic:40-270 mmHg
diastolic:10-215 mmHg
pediatrics:
systolic:40-200 mmHg
diastolic:10-150 mmHg
Neonate:
systolic:40-140 mmHg
diastolic:10-100 mmHg
Error:
Max mean error: ±5
mmHg | Method: Oscillometry
Range:
Adult:
systolic: 40-270mmHg
diastolic: 10-215mmHg
pediatrics:
systolic:40-200mmHg
diastolic:10-150mmHg
Neonate:
systolic:40-135mmHg
diastolic:10-100mmHg
Error:
Max mean error: ±5
mmHg | Same |
| | Max standard deviation: 8 mmHg | Max standard deviation: 8 mmHg | |
| Temperat
ure
(Temp.) | Method: Thermal resistance
Range: 0-50°C
Accuracy: ±0.1°C | Method: Thermal resistance
Range: 0-50°C
Accuracy: ±0.1°C | Same |
| Carbon
dioxide
(CO2) | Method: Infrared absorption
Masimo Sidestream/
Mainstream CO2
Module:
Range: 0-190mmHg,
0
AwRR:0
Accuracy: All
environment:
0mmHg114mmHg:150mmHg/
$±(2.25mmHg+reading×4%)$
114 mmHg -190
mmHg: not defined.
Respironics
Sidestream/Mainstream CO2 module:
Range: 0 mmHg
/0%19.7% /0 kPa20.0kPa(at760mmHg)
Accuracy: 040mmHg:70mmHg:
±2mmHg
41
$±5%×reading$
71100mmHg:150mmHg:
$±8%×reading$
101
$±10%×reading$ ;
awRR
range: 0, 2150bpm;25% (at 760mmHg)
Accuracy: ±1bpm | Method: Infrared absorption
Masimo Sidestream/
Mainstream CO2
Module:
Range: 0-190mmHg,
0
AwRR:0150rpm;114mmHg:
Accuracy: All
environment:
0mmHg
$±(2.25mmHg+reading×4%)$
114 mmHg -190
mmHg: not defined.
Respironics
Sidestream/Mainstream CO2 module:
Range: 0 mmHg150mmHg/40mmHg:
0%19.7% /0 kPa20.0kPa(at760mmHg)
Accuracy: 0
±2mmHg
4170mmHg:100mmHg:
$±5%×reading$
71
$±8%×reading$
101150mmHg:150bpm;
$±10%×reading$ ;
awRR
range: 0, 2
Accuracy: ±1bpm | Same |
| invasive
blood
pressure(I
BP) | Method: Direct invasive measurement
Range: -50 to 300 mmHg | Method: Direct invasive measurement
Range: -50 to 300 mmHg | Same |
| | Accuracy: ±2% or ±1 mmHg, whichever is greater (excluding the sensor error) | Accuracy: ±2% or ±1 mmHg, whichever is greater (excluding the sensor error) | |
| cardiac
output
(C.O.) | Method:
Thermodilution method
Range: 0.1 to 20 L/min
Accuracy: ±5% or ±0.1 L/min, whichever is greater | Method:
Thermodilution method
Range: 0.1 to 20 L/min
Accuracy: ±5% or ±0.1 L/min, whichever is greater | Same |
| anesthetic
gas (AG) | Method: Infrared absorption
Range:
CO2: 0%~25%
N2O: 0%~100%
Hal: 0%~25%
Enf: 0%~25%
Iso: 0%~25%
Sev: 0%~25%
Des: 0%~25%
O2: 0%100%150rpm
awRR: 0
Accuracy:
CO2: 0%~15%:
$±(0.2%+reading×2%)$
15%~25%: Not defined.
N2O:
$±(2%+reading×2%)$
Hal, Enf, Iso:
0%~8%: $±(0.15 %+reading×5%)$
8%-25%: Not defined.
Sev: 0%-10%:
$±(0.15 %+reading×5%)$
10%~25%: Not defined.
Des: 0%~22%:
$±(0.15 %+reading×5%)$
22%~25%: Not defined.
O2: $±(1%+reading×2%)$
awRR: ±1rpm | Method: Infrared absorption
Range:
CO2: 0%~25%
N2O: 0%~100%
Hal: 0%~25%
Enf: 0%~25%
Iso: 0%~25%
Sev: 0%~25%
Des: 0%~25%
O2: 0%100%150rpm
awRR: 0
Accuracy:
CO2: 0%~15%:
$±(0.2 kPa+reading×2%)$
Not defined.
N2O: $±(2 kPa+reading×2%)$
Hal, Enf, Iso:
0%~8%:
$±(0.15%+reading×5%)$
Not defined.
Sev: 0%-10%:
$±(0.15%+reading×5%)$
Not defined.
Des: 0%-22%:
$±(0.15%+reading×5%)$
22%~25%: Not defined.
O2: $±(1%+reading×2%)$
awRR: ±1rpm | Same |
7
8
9
10
11
| BIS | Range and accuracy: | Range and Accuracy: | Same | |
|---|---|---|---|---|
| SQI: 0-100%; accuracy: | ||||
| 1%. | BIS: 0-100; accuracy: | |||
| 1%. | ||||
| EMG: 0~100dB; | ||||
| accuracy: 1%. | SQI: 0-100%; accuracy: | |||
| 1%. | ||||
| BIS: 0-100; accuracy: | ||||
| 1%. | EMG: 0~100dB; | |||
| accuracy: 1%. | ||||
| SR: 0~100%; accuracy: | ||||
| 1%. | ESR: 0~100%; | |||
| accuracy: 1%. | ||||
| Substantial Equivalence Conclusion: | ||||
| The above-detailed technical specification comparison for each parameter between the | ||||
| subject device and the predicate devices (C50 and C80 multi-parameter patient monitor) | ||||
| shows the difference lies in monitor size and Comen SpO2. Therefore, we declared that | ||||
| the NC10 and NC12 Multi-parameter Patient Monitors can be found substantially | ||||
| equivalent to the predicate device. | ||||
| Performance | ||||
| Data | The following performance data are provided to support the substantial equivalence | |||
| determination. | ||||
| Software Verification and Validation Testing | ||||
| Software verification and validation testing were conducted, and documentation was | ||||
| provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for | ||||
| the Content of Premarket Submissions for Software Contained in Medical Devices." | ||||
| Biocompatibility Testing | ||||
| The accessories with patient contact have been evaluated by biocompatibility testing in | ||||
| accordance with ISO 10993-1. | ||||
| Bench test | ||||
| The NC10 and NC12 Multi-parameter Patient Monitor have been tested and found to be in | ||||
| compliance with the following safety, performance and electromagnetic compatibility | ||||
| standards: | ||||
| ● | ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012Medical Electrical Equipment - | |||
| Part 1: General Requirements For Basic Safety And Essential Performance (IEC | ||||
| 60601-1:2005, MOD) | ||||
| ● | IEC 60601-1-2 Edition 4.0: 2014-02 Medical Electrical Equipment - Part 1-2: General | |||
| Requirements For Basic Safety And Essential Performance - Collateral Standard: | ||||
| Electromagnetic Compatibility - Requirements And Tests | ||||
| ● | IEC 60601-1-8 Edition 2.1 2012-11Medical Electrical Equipment - Part 1-8: General | |||
| Requirements For Basic Safety And Essential Performance - Collateral Standard: | ||||
| General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical | ||||
| Equipment And Medical Electrical Systems | ||||
| ● | IEC 60601-2-27 Edition 3.0 2011-03 Medical Electrical Equipment - Part 2-27: | |||
| Particular Requirements For The Basic Safety And Essential Performance Of | ||||
| Electrocardiographic Monitoring Equipment [Including: Corrigendum 1 (2012)] |
12
| • | IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30:
Particular requirements for the basic safety and essential performance of automated
non-invasive sphygmomanometers |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • | IEC 60601-2-34 Edition 3.0 2011-05 Medical Electrical Equipment - Part 2-34:
Particular Requirements For The Basic Safety, Including Essential Performance, Of
Invasive Blood Pressure Monitoring Equipment |
| • | ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56:
Particular requirements for basic safety and essential performance of clinical
thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. |
| • | ISO 80601-2-61 Second Edition 2017-12 Medical Electrical Equipment - Part 2-61:
Particular Requirements For Basic Safety And Essential Performance Of Pulse
Oximeter Equipment |
| • | ISO 80601-2-55 Second Edition 2018-02 Medical Electrical Equipment - Part 2-55:
Particular Requirements For The Basic Safety And Essential Performance Of
Respiratory Gas Monitors |
| • | ANSI AAMI EC57:2012 Testing And Reporting Performance Results Of Cardiac
Rhythm And ST-Segment Measurement Algorithms |
| • | IEC 80601-2-49:2018 Medical electrical equipment - Part 2-49: Particular
requirements for the basic safety and essential performance of multifunction patient
monitoring equipment. |
| • | IEC 80601-2-26:2019 Medical electrical equipment - Part 2-26: Particular
requirements for the basic safety and essential performance of electroencephalographs. |
| • | EN 1060-1:1995+A2:2009 Non-invasive sphygmomanometers - Part 1: Requirements
and test methods for non-automated measurement type |
| • | EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring
systems |
| • | IEC 60601-1-6 Edition 3.1 2013-10 Medical Electrical Equipment - Part 1-6: General
Requirements For Basic Safety And Essential Performance - Collateral Standard:
Usability |
| • | IEC 62366-1 Edition 1.0 2015-02 Medical Devices - Part 1: Application Of Usability
Engineering To Medical Devices [Including CORRIGENDUM 1 (2016)] |
| • | ISO 14971 Third Edition 2019-12 Medical devices - Application of risk
management to medical devices |
| | Clinical studies |
| | The clinical accuracy of non-invasive blood pressure (NIBP) determination, SpO2
measurement, and respiratory rate were validated for the intended patient population.
Clinical data is provided to support the determination of substantial equivalence with
predicated devices that are currently marketed for the same intended use. |
| • | The accuracy of the SpO2 accuracy during non-motion conditions as compared to CO-
oximetry in a controlled desaturation study was validated using the method outlined in |
| | ISO 80601-2-61:2017 and the FDA guidance Pulse Oximeters - Premarket Notification
Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration
Staff, March 2013. |
| | • The clinical accuracy of non-invasive blood pressure determination was validated
according to ISO 81060-2 which contains the requirements for clinical accuracy and
the protocols for investigating the NIBP determination clinical accuracy. |
| | • The clinical accuracy of respiratory rate was validated by clinical testing to compare
the measurement of the subject device and that of a clinician-scored capnography
device, manually scored end-tidal CO2 (EtCO2) capnography. |
| | All clinical accuracy validation studies were conducted in accordance with standard ISO
14155:2020. |
| | Summary
Based on the non-clinical and clinical performance above, we demonstrate that the NC10
and NC12 multi-parameter patient monitors were substantially equivalent and perform as
well as the predicate device. |
| Conclusion: | The NC10 and NC12 Multi-Parameter Patient Monitor are substantially equivalent to the
predicate devices (C50 and C80 multi-parameter patient monitor, K191106) in terms of
indication for use and technological characteristics. Performance testing and compliance
with FDA-recognized consensus standards demonstrate that NC10/NC12 are
substantially equivalent to the predicate device. |
13